The Implementing Regulation (EU) 2020/1207 of the European Commission of August 19th 2020, published in the Official Journal, lays down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards common specifications for the reprocessing of single-use devices.
As a reminder, Regulation (EU) 2017/745 allows reprocessing of single-use devices only where it is permitted by national law. One of the conditions for such reprocessing is that it is performed in accordance with common specifications.
These common specifications are based on risk management aiming at ensuring the safety and performance of reprocessed single-use medical devices. Health institutions and, where applicable, external reprocessors, are responsible for the safety and performance of the reprocessed device and should have a quality management system in place to ensure compliance with the applicable requirements.